SUE FORM A: NOTIFICATION OF SUE BY RESPONSIBLE PERSON OR DISTRIBUTOR

TO COMPETENT AUTHORITY
(according to Article 23 of Regulation (EC) No 1223/2009 on cosmetic products)
1) Case report

2) Company

Company report number:

Competent Authority code number:
Type of the report:
Initial
Follow-up

Distributor

Responsible person

Company name:
Final

Address and local contact details:

Date received by company: dd/mm/yyyy

Sending date to Competent Authority: dd/mm/yyyy

3) Seriousness criteria
Temporary or permanent functional incapacity
Disability
Hospitalization

Congenital anomalies
Immediate vital risk
Death

4) Primary reporter

5) End user

Consumer

Code:

Health professional

Age (at time of SUE):

Other (specify):

Sex:

Female

Date of birth: yyyy

Male

Unknown

Has the reported information been confirmed by a medical

professional :
Yes
No

Country of residence:

6) Suspected product

7) Description of serious undesirable effect (SUE)

a) Full name of suspected product

a) Type of effect

-Country of occurrence:

Company:

-Date of onset: dd/mm/yyyy

Category of product:

-Time from the beginning of use to onset of first symptoms:

(minutes/ hours/days/months)
-Time from last use to onset of first symptoms:

Batch number:
Notification number:

(minutes/ hours/days/months)

b) Use of product

-Reported signs/ symptoms:

Date of first ever use: dd/mm/yyyy

Frequency of use: times per (day/week/month/year)
Professional use:

Yes

No

-Reported diagnosis (if any):

Application site(s):

b) Location of SUE

Product use stopped :

Yes

No

N/A

Skin, area(s) concerned :

Scalp
Hair
Eyes
Teeth
Lips
Mucosae, specify:
Others, specify:

Unknown

Date of stopping the product use: dd/mm/yyyy

c) Re-exposure to the suspected product

Positive

Negative

Not performed

Nails

Unknown
SUE in area of product application

d) Other suspected cosmetic products used concomitantly:

SUE out of area of product application

Complementary information can be attached to the document /related in

the narrative

8) Outcome of SUE(s)
If recovered, specify the time for recovering:

Recovered
Improving

Aftereffects (sequalae)

Ongoing

Version: 11 July 2013

Unknown

Other:

9) Relevant underlying conditions

Yes

No

Unknown
If yes, specify :
Relevant treatment(s):
Additional concurrent use of other products (drugs, food supplements, ...):
10) Relevant medical information / history
Allergic diseases, specify:
If tests previously performed, specify the type and results:

Cutaneous diseases, specify:

Other relevant underlying disease(s):
Skin specificities including phototype:
Others (example: specific climatic conditions or specific exposure):
11) Case management
a) Treatment(s) of SUE
Drug prescription: Name of product (INN)

Dose

Duration

b) Other measure(s):
Duration / complementary details:
c) Seriousness of undesirable effect
c-1) Functional incapacity (if applicable)
Description:
If temporary, specify the duration:
Expert evaluation available
Corrective treatment of the functional incapacity:

Medical certificate available

c-2) Disability (if applicable), specify the %:

Description:
Expert evaluation available

Medical certificate available

c-3) Hospitalization (if applicable):

Duration of hospitalization:
Hospital name and address:
Corrective treatment received during the hospitalization:
Drug prescription: Name of product (INN)

Treatment /measure taken after hospitalization:

Dose

Duration

c-4) Congenital anomalies (if applicable) :

Detected during pregnancy
Detected after delivery

Expert evaluation available

c-5) Immediate vital risk (if applicable):

Treatment and specific measures:
c-6) Death (if applicable):
Date: dd/mm/yyyy
Diagnosis:

Medical certificate available

Version: 11 July 2013

12) Complementary investigations

Yes

No

If yes , specify :

Allergic testing :
Skin test(s) performed with the suspected cosmetic product(s) :
Product(s) tested

Method(s) used

Readings on

Results

Skin test(s) performed with the substances (if available, attach the complete results to this form)
Other results of allergic testing: ..
Other additional investigation(s) (specify, including results):

13 ) Summary from Responsible Person or Distributor

a) Narrative

b) Follow-up

Specify Competent Authority case identification number (if available):

c) Causality assessment
Very likely

Likely

Not clearly attributable

Unlikely

Excluded

Unassessable

d) Management
Has this SUE already been submitted to a Competent Authority?:
If yes, to which Competent Authority was it reported? :

Yes

No

Unknown

e) Corrective actions
Yes

No

If yes , specify :

f) Comments

Version: 11 July 2013